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FDA Approves Genentech’s Lucentis (ranibizumab injection) 0.3 mg Prefilled Syringe for Diabetic Macu biospace
March 22, 2018
Genentech, Inc., a member of the Roche Group today announced that FDA approved the Lucentis® 0.3 mg prefilled syringe (PFS) as a new method of administering the medicine to treat all forms of diabetic retinopathy
Seattle Genetics Gains Another FDA Approval biospace
March 22, 2018
Seattle Genetics, Inc. announced that FDA had approved its Adcetris in combination with chemotherapy in adults with previously untreated Stage III or IV classical Hodgkin lymphoma.
USFDA grants priority to XTANDI's sNDA biospectrumasia
March 21, 2018
When approved, the sNDA would expand the indication of XTANDI to include men with non-metastatic Castration-Resistant Prostate Cancer
Exactech’s Vitamin E Acetabular Polyethylene Liner for Hip Replacement Gains FDA 510(k) Clearance biospace
March 21, 2018
Exactech, Inc., announced today it has received 510(k) clearance from FDA to market the Novation XLE Vitamin E acetabular polyethylene liners for hip replacement surgery.
FDA Grants Priority Review for Prostate Cancer Treatment biospace
March 21, 2018
Pfizer and Astellas Pharmaceuticals Say to Apply for Supplementary New Drugs for US Food and Drug Administration
FDA grants Fast Track designation to nintedanib for the treatment of systemic sclerosis with associa biospace
March 20, 2018
Boehringer Ingelheim Pharmaceuticals, Inc. announced today that FDA has granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease
Amplyx Pharmaceuticals Receives Fourth "Qualified Infectious Disease Product" (QIDP) Desig biospace
March 20, 2018
Amplyx Pharmaceuticals, today announced that the FDA has granted a fourth Qualified Infectious Disease Product (QIDP) designation to APX001, the company's lead antifungal product candidate.
Janssen’s urothelial cancer drug gets breakthrough therapy designation pharmaceutical-technology
March 19, 2018
The US Food and Drug Administration (FDA) has awarded breakthrough therapy designation to Janssen Pharmaceutical’s erdafitinib for the treatment of patients with urothelial cancer.
Abeona Receives FDA Rare Pediatric Disease Designation for ABO-202 Gene Therapy Program in CLN1 Dise americanpharmaceuticalreview
March 19, 2018
Abeona Therapeutics announced the FDA has granted Rare Pediatric Disease Designation for the ABO-202 program an AAV-based gene therapy for the treatment of CLN1 disease
FDA Approves Hizentra americanpharmaceuticalreview
March 19, 2018
CSL Behring announced the U.S. Food and Drug Administration (FDA) approved Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid)

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